Will hernia mesh be as controversial as vaginal mesh?

26-Jan-2018

Experts comment on whether NICE recommendation against use of vaginal mesh implants could be expanded to hernia repair devices

The decision last month by the National Institute for Health and Care Excellence (NICE) ruling against continued use of vaginal mesh implants for pelvic organ prolapse is expected to lead to calls for more evidence on the efficacy of similar hernia mesh repair devices.

Claims regarding the use of mesh in hernia repair have re-entered the spotlight in recent months due to the widely-reported concerns relating to its use in pelvic or vaginal procedures

The healthcare guidance and standards agency ruled in December that evidence for the long-term efficacy of vaginal mesh implants was ‘inadequate in quality and quantity’.

Fresh guidelines state that, while the devices can still be used to treat stress-urinary incontinence (SUI) and to repair hernias in men or women; mesh repair for pelvic organ prolapse (POP) should only be used for research purposes.

The recommendation came after it was revealed that more than 800 women are taking legal action against the NHS and one of the biggest manufacturers of vaginal mesh implants, US pharmaceutical giant, Johnson and Johnson.

Used to treat pelvic organ prolapse and incontinence after childbirth, some implants have been found to cut into the vagina, causing severe discomfort.

Some women have been left in permanent pain, unable to walk or work, with one calling the implants ‘barbaric’.

Other women report that their partners have been injured by the mesh during intercourse and that they have suffered severe injuries.

Made from polypropylene, the meshes are made by different companies and there are several different types.

And, according to NHS data, between April 2007 and March 2015, some 92,000 women have had them fitted.

While the NHS is not compelled to act on the new NICE guidelines, experts believe it will amount to a de facto ban.

Now, a month on from the announcement, they are predicting that, despite the comments supporting continued used of the devices for hernia treatment; a similar review may be necessary.

Speaking to BBH, Christian Beadell, a senior solicitor at Fletchers Solicitors, one of the UK’s leading medical negligence law firms, said: “Claims regarding the use of mesh in hernia repair have re-entered the spotlight in recent months due to the widely-reported concerns relating to its use in pelvic or vaginal procedures.

“The mesh types themselves are similar and give rise to comparable complications, such as pain, infection, erosion, migration and shrinkage. But,in the case of hernia repair, they are also associated with recurrence and bowel obstruction.

There are well-reported issues with mesh repairs, but as with all medical devices, the decision to ban or restrict their general use will be determined by whether complication rates become unacceptable

“While vaginal mesh has been banned in several countries; a certain number of hernia meshes have also been withdrawn from the market due to concerns about their safety over the years. For example, the Ethicon Physiomesh was subject to worldwide recall in 2016 after unreported studies showed there was a higher rate of recurrence or re-operation compared to other similar meshes.”

He added that the Medicines and Healthcare products Regulatory Agency in the UK is not conducting any studies on hernia mesh use and considers them in principle to be safe; and the Mesh Oversight Group report from 2017 specifically limited its findings to mesh used only in the pelvic region, and did not take hernia mesh into account.

“There are well-reported issues with mesh repairs, but as with all medical devices, the decision to ban or restrict their general use will be determined by whether complication rates become unacceptable,” he said.

“So where does this leave us? Vaginal mesh claims certainly have a head start, but if a patient has a complication from a hernia mesh repair, the standard response will still be ‘this is a recognised, non-negligent complication and the mesh is safe for use’.

“Until such time that there is definitive evidence of long-term complications, or concerted action by the regulatory bodies; hernia mesh compensation claims are likely to be isolated to individual cases.”